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NCT Number: NCT07745998

The BRIGHT Study (Device Name: HALO System)

The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by demonstrating sensor's accuracy and stability and 2) to confirm safe implantation of the Sensor and safety of the device during implantation.

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Key information

Conditions

Diabetes Mellitus - Type 1 Acid-Base Imbalance Acidosis Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus - Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Ketoacidosis Endocrine System Diseases Glucose Metabolism Disorders Hyperglycaemia (Diabetic) Hyperglycemia Hypoglycemia Hypoglycemia (Diabetic) Immune System Diseases Ketoacidosis, Diabetic Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Indigo Diabetes N.V. is currently developing an active implantable medical device, intended to be used for real time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in persons living with diabetes mellitus. The device will be intended for non-adjunctive use and allow integration into hybrid closed loop systems.

In this context, Indigo has developed a first and second prototype, which were used in early feasibility studies in humans (GLOW and SHINE study, respectively). Based on the outcome of these investigations, Indigo developed a third prototype: the HALO SYSTEM, which will be used during the current clinical investigation (BRIGHT study). The system is not substantially similar to any other device currently available on the EU or US markets, since it combines continuous measurement of glucose with continuous ketone (more specifically; β-hydroxybutyrate) and lactate measurement.

After demonstrating safety in previous studies (GLOW and SHINE), the primary intend of the BRIGHT study is demonstrate sensor accuracy and stability througout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign an informed consent form
  • Age ≥ 18 years
  • Willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate challenges)
  • Willing to charge the SENSOR on daily basis
  • Willing not to insert their standard CGM and/or insulin pump in and around the SENSOR implant site (± radius 5 cm)[TS| XR1.1] Diagnosed with type 1 diabetes mellitus according to the World Health Organization criteria, for at least 12 months prior to screening, on CSII therapy

Exclusion criteria

  • Known allergy to polydimethylsiloxane (PDMS)
  • A contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
  • History of hepatitis C or HIV or other disease transmissible by blood
  • A condition requiring or likely to require magnetic resonance imaging during the study duration
  • Female participants who are pregnant, planning on becoming pregnant or nursing
  • Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
  • Anemia identified by a haemoglobin <14 g/dL for men or <12 g/dL for women
  • The presence of any other active implanted device
  • The presence of any other CGM sensor/pump located in the lower abdomen (other location is acceptable)
  • Waist circumference of >120 cm
  • Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.

Treatment and study plan

The HALO System

Device

The FUSHO3 sensor, which is part of the HALO System, is a continuous multi-metabolite monitoring (CMM) sensor which is a miniaturized near-infrared spectrometer that measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites

Primary outcomes

  1. Primary performance objective: Demonstration of Sensor accuracy

    Time frame: 3 months

    Evaluate the accuracy of the Algorithm with an in-factory-calibrated on-sensor model used by the Sensor to generate blood glucose, ketone and lactate concentration values by comparing these values to those of a venous blood reference method and develop an upgraded Algorithm to increase the accuracy of the HALO System by off-sensor model optimisations, using real-time insights and historical experimental data.

  2. Primary performance objective: Demonstration of Sensor stability

    Time frame: 3 months

    confirm the accuracy of the Algorithm for glucose, ketones and lactate throughout 3 months of implantation, compared to blood reference measurements using an in-factory-calibrated on-sensor model AND using an optimised off-sensor model.

  3. Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety)

    Time frame: 30 days

    Incidence of Sensor insertion procedure-related SAEs within 30 days from implantation.

  4. Primary safety objective: Confirm the safety of the device during the implantation period

    Time frame: 3 months

    Assessment of device-related AEs during 3 months of implant use and all SAEs collected throughout the study.

Secondary outcomes

  1. Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure

    Time frame: 30 days

    • Successful Sensor implantation (first implant in case of re-implant) procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure-related SAEs.
    • Successful Sensor explantation procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure-related SAEs.
    • Procedural success defined as implantation of the Sensor within an average of 20 minutes (from start incision to closing of skin) without the occurrence of procedure-related AEs up to 30 days after implantation.
    • Wound status at each visit.
    • Final result on healing at explantation.

  2. Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety)

    Time frame: 14 days

    Incidence of Sensor removal-related SAEs within 14 days from explantation

Other outcomes

  1. Exploratory study objective: Compare daily measurement performance to the participant's standard CGM system.

    Time frame: 3 months

    Reported MARD for HALO System vs. the participant's standard CGM system.

  2. Participant and Surgeon Usability and Satisfaction Assessed via the HALO Usability Test Form

    Time frame: 3 months

    Usability and satisfaction assessed using the study-specific "HALO Usability Test Form," for participants and implanting surgeons.

    Participant version rates the implant procedure, device comfort, healing, and daily-life impact on a 4-point scale, plus a structured usability section covering the manual, sensor (FUSHO3), charger, and App. Items use either a comfort scale (1 = "very uncomfortable" to 4 = "very comfortable," or 1 = "big impact" to 4 = "no impact," with higher scores indicating a better outcome) or 4-point agreement scale (1 = "strongly disagree" to 4 = "strongly agree," - so higher agreement reflects a worse outcome for those specific items).

    The surgeon version additionally records procedure duration and rates confidence in correct implantation (1 = "extremely unconfident"to 4 = "extremely confident," higher = better), plus a 10-item section on the implantation procedure (packaging, pocket preparation, tools, training needs), with 1-4 "strongly (dis)agree and free text

Study contacts

Contact information is provided by the study sponsor or research team.

Gijs Klarenbeek, Dr.

CONTACT

[email protected]

479 98 64 58 ext. +32

Sponsors and collaborators

Lead sponsor

Indigo Diabetes NV

Industry

Registry information

Official study title

The BRIGHT Study, an Open Label, Single-arm, Interventional, Multicenter, Prospective Study of the Diagnostic Feasibility of the HALO System, Designed to Evaluate the Safety and Performance of the HALO SYSTEM in Subjects With Diabetes Mellitus

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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